Trial record 1 of 1 for:
Thalidomide AND "Marwan Sabbagh"
Thalidomide for Patients With Mild to Moderate Alzheimer's Disease
This study is currently recruiting participants.
Verified August 2012 by Banner Health
Sponsor:
Banner Health
Information provided by (Responsible Party):
Brian Browne, Banner Health
ClinicalTrials.gov Identifier:
NCT01094340
First received: March 25, 2010
Last updated: August 6, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This is a 24-week, randomized, double-blind, placebo-controlled study of the effect of thalidomide and placebo on CSF (cerebral spinal fluid) and plasma biomarkers in patients with mild to moderate Alzheimer's disease. This study will evaluate the effects of 24 weeks of treatment with Thalidomide on plasma biomarkers.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: Thalidomide |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | "Twenty-Four-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fixed Dose Regimens of Thalidomide and Placebo on CSF and Plasma Biomarkers in Patients With Mild to Moderate Alzheimer's Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
Drug Information available for:
Thalidomide
U.S. FDA Resources
Further study details as provided by Banner Health:
Primary Outcome Measures:
- Improve cognition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Thalidoide
CSF
|
Drug: Thalidomide
fixed dose over 8 clinic visits
Other Name: Celegene
|
Detailed Description:
A lumbar puncture will be done before treatment (baseline), and at 24 weeks to collect CSF for the quantification of biomarkers. As an exploratory effort, we will test the effects of thalidomide on the same biomarkers in the plasma and will determine if detectable changes mirror changes observed in the CSF.
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects must have a screening diagnosis of Probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
- Subjects must have a Mini-Mental State Examination (MMSE) score of 12-26
- Subject must live at home.
- Must have a caregiver to participate in this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094340
Locations
| United States, Arizona | |
| Banner Sun Health Research Institute | Recruiting |
| Sun City, Arizona, United States, 85351 | |
| Contact: Marwan Sabbagh, MD 623-832-6500 marwan.sabbagh@bannerhealth.com | |
| Principal Investigator: Marwan N Sabbagh, MD | |
Sponsors and Collaborators
Banner Health
Investigators
| Study Director: | Carolyn Liebsack, BSN | Banner Sun Health Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Brian Browne, MARWAN SABBAGH, MD Director, Banner Health |
| ClinicalTrials.gov Identifier: | NCT01094340 History of Changes |
| Other Study ID Numbers: | 1R01AG034155-01 |
| Study First Received: | March 25, 2010 |
| Last Updated: | August 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Thalidomide Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 17, 2013